STI Prophylaxis and Emergence of Antimicrobial Resistance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Detection of antimicrobial resistance genes of interest and characterisation of microbiome
研究概览
简要总结
The goal of this observational study is to understand the risk of antibiotic resistance and changes in the human microbiome (bacteria that live inside and on us), if people use antibiotics to prevent sexually transmitted infections (STI prophylaxis, doxycycline post-exposure prophylaxis, or 'doxyPEP'). The study will assess how easy and acceptable it is to find antibiotic resistance and microbiome changes in the throats and guts of men-who-have-sex-with-men (MSM) who use STI prophylaxis.
The study will recruit 108 MSM who are using and not using STI prophylaxis. Participants will visit the clinic every 6 months. At each visit, they will provide a throat swab and stool sample, and complete a questionnaire. DNA of the bacteria from the samples will be analysed to identify the bacteria and look for antibiotic resistance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 18 years.
- •Identifies as a man (cis or trans).
- •Has sex with men.
- •Able to provide informed consent.
排除标准
- •Use of an antibiotic other than doxycycline in the 3 months prior to enrolment
- •Currently being treated for an STI with doxycycline
- •Use of doxycycline within the prior 3 months for an indication other than STI treatment or STI prevention.
结局指标
主要结局
Detection of antimicrobial resistance genes of interest and characterisation of microbiome
时间窗: From enrolment to 12 months
The successful detection of antimicrobial resistance genes of interest (tetracycline and other antibiotic classes) and identification of bacterial species (microbiome) and in the oropharynx and gastrointestinal tract.
次要结局
- Detection of differences in prevalence of antimicrobial resistance genes of interest between people using and not using antibiotic STI prophylaxis.(From enrolment to 12 months)
- Detection of differences in microbiome between people using and not using antibiotic STI prophylaxis.(From enrolment to 12 months)
- Change over time in prevalence of antimicrobial resistance genes of interest between people using and not using antibiotic STI prophylaxis.(From enrolment to 12 months)
- Change over time in microbiome between people using and not using antibiotic STI prophylaxis.(From enrolment to 12 months)